{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:20:38Z","timestamp":1790806838270,"version":"4.1.0"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"14","license":[{"start":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T00:00:00Z","timestamp":1693526400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T00:00:00Z","timestamp":1693526400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2023,9]]},"DOI":"10.1007\/s40265-023-01933-1","type":"journal-article","created":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T10:02:52Z","timestamp":1693562572000},"page":"1341-1347","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":45,"title":["Rozanolixizumab: First Approval"],"prefix":"10.1007","volume":"83","author":[{"given":"Sheridan M.","family":"Hoy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,9,1]]},"reference":[{"key":"1933_CR1","unstructured":"National Institute of Neurological Disorders and Stroke. Myasthenia Gravis Fact Sheet. 2023. https:\/\/www.ninds.nih.gov\/myasthenia-gravis-fact-sheet. Accessed 19 Jul 2023."},{"issue":"8","key":"1933_CR2","doi-asserted-by":"publisher","first-page":"865","DOI":"10.1007\/s40265-022-01726-y","volume":"82","author":"D Menon","year":"2022","unstructured":"Menon D, Bril V. Pharmacotherapy of generalized myasthenia gravis with special emphasis on newer biologicals. Drugs. 2022;82(8):865\u201387.","journal-title":"Drugs"},{"issue":"10","key":"1933_CR3","doi-asserted-by":"publisher","first-page":"597","DOI":"10.1038\/s41582-021-00547-z","volume":"17","author":"JD Lunemann","year":"2021","unstructured":"Lunemann JD. Getting specific: targeting Fc receptors in myasthenia gravis. Nat Rev Neurol. 2021;17(10):597\u20138.","journal-title":"Nat Rev Neurol"},{"key":"1933_CR4","unstructured":"UCB Inc. UCB announces U.S. FDA approval of RYSTIGGO\u00ae (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis [media release]. 27 Jun 2023. https:\/\/www.ucb.com\/stories-media\/Press-Releases"},{"key":"1933_CR5","unstructured":"UCB Inc. RYSTIGGO\u00ae (rozanolixizumab-noli) injection, for subcutaneous use: US prescribing information. 2023. https:\/\/www.ucb-usa.com\/RYSTIGGO-prescribing-information.pdf. Accessed 18 Jul 2023."},{"key":"1933_CR6","unstructured":"US FDA. FDA Roundup: June 27, 2023 [media release]. 27 Jun 2023. https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-roundup-june-27-2023."},{"key":"1933_CR7","unstructured":"UCB Inc. UCB presents final results from phase II study of rozanolixizumab in primary immune thrombocytopenia (ITP) at 2019 ASH Annual Meeting [media release]. 9 Dec 2019. http:\/\/www.ucb.com."},{"key":"1933_CR8","unstructured":"UCB Inc. UCB pipeline. 2023. https:\/\/www.ucb.com\/our-science\/pipeline. Accessed 26 Jul 2023."},{"issue":"7","key":"1933_CR9","first-page":"1111","volume":"10","author":"B Smith","year":"2018","unstructured":"Smith B, Kiessling A, Lledo-Garcia R, et al. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018;10(7):1111\u201330.","journal-title":"MAbs"},{"issue":"414","key":"1933_CR10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1126\/scitranslmed.aan1208","volume":"9","author":"P Kiessling","year":"2017","unstructured":"Kiessling P, Lledo-Garcia R, Watanabe S, et al. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: a randomized phase 1 study. Sci Transl Med. 2017;9(414):1\u201312.","journal-title":"Sci Transl Med."},{"issue":"6","key":"1933_CR11","doi-asserted-by":"publisher","first-page":"e853","DOI":"10.1212\/WNL.0000000000011108","volume":"96","author":"V Bril","year":"2021","unstructured":"Bril V, Benatar M, Andersen H, et al. Efficacy and safety of rozanolixizumab in moderate to severe generalized myasthenia gravis: a phase 2 randomized control trial. Neurology. 2021;96(6):e853\u201365.","journal-title":"Neurology"},{"issue":"5","key":"1933_CR12","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1016\/S1474-4422(23)00077-7","volume":"22","author":"V Bril","year":"2023","unstructured":"Bril V, Dru\u017cd\u017c A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383\u201394.","journal-title":"Lancet Neurol"},{"key":"1933_CR13","doi-asserted-by":"crossref","unstructured":"Bril V, Druzdz A, Grosskreutz J, et al. Long-term efficacy and safety of symptom-driven cyclic rozanolixizumab treatment in patients with generalized myasthenia gravis: a pooled analysis of a phase 3 study and two open-label extension studies [abstract no. P1-5.012]. Neurology. 2023;100(17 Suppl 2).","DOI":"10.1212\/WNL.0000000000203497"}],"updated-by":[{"DOI":"10.1007\/s40265-023-01960-y","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2023,10,20]],"date-time":"2023-10-20T00:00:00Z","timestamp":1697760000000}}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-023-01933-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-023-01933-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-023-01933-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,22]],"date-time":"2023-10-22T06:02:40Z","timestamp":1697954560000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-023-01933-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9]]},"references-count":13,"journal-issue":{"issue":"14","published-print":{"date-parts":[[2023,9]]}},"alternative-id":["1933"],"URL":"https:\/\/doi.org\/10.1007\/s40265-023-01933-1","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9]]},"assertion":[{"value":"1 September 2023","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 October 2023","order":2,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":3,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":4,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s40265-023-01960-y","URL":"https:\/\/doi.org\/10.1007\/s40265-023-01960-y","order":5,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd\/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}